Scoring balloon with translating scoring wires

ABSTRACT

A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.

BACKGROUND OF THE INVENTION

Balloon dilatation catheters are used to treat lesions in vessels.However, difficulties are encountered in navigating tortuous anatomy andsafely crossing very tight lesions. Moreover, some lesions are difficultto dilate using just a balloon, and require a focused force to dilatethe lesion at safe inflation pressures.

U.S. Pat. No. 6,394,995 to Solar et al. describes a system used toprovide enhanced force to treat a lesion. This system has a flexibleadvancement member with a tracking member slidable over a guidewire, anda balloon having a distal end attached to the tracking member. But thistype of system provides limited focused force and lacks pushability andmaneuverability.

SUMMARY OF THE INVENTION

The present invention provides a scoring balloon catheter that can beused for treating vascular lesions. In use, the balloon presses scoringwires into the lesion. The catheter includes a shaft; an inflatableballoon mounted on the shaft's distal section; a member or springassociated with the shaft, proximal to the balloon; and at least onescoring wire. In some embodiments the scoring wire has a fixed endmounted on the shaft between the shaft's distal end and the balloon. Thescoring wire has a longitudinally movable end associated with the memberor spring; and an intermediate portion disposed outside of the balloon.

In some embodiments the movable scoring-wire ends are the proximal endsof the wires. These ends extend into lumens in the member. In some ofthese embodiments, the member comprises or interacts with alongitudinally resilient member such as an elastic polymer or rubber ora spring. In some embodiments, the device further comprises a secondmember in which the spring sits between the member and the secondmember.

In some embodiments, the device comprises scoring wire lumens inside oroutside of the shaft. These scoring wire lumens contain one or morescoring wires. In some embodiments, the device comprises two lumensinside of the shaft and two scoring wires inside of the lumens.

In other embodiments, the scoring balloon catheter uses a spring mountedwithin a hub on a handle assembly. The shaft passes through the springand extends into the handle assembly. A hub cover sits over the shaftand over the hub. In some cases, the hub cover provides strain relieveto the hub-spring connection. The scoring wires are welded or otherwiseattached to the spring.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further advantages of the present invention may be betterunderstood by referring to the following description in conjunction withthe accompanying drawings in which:

FIG. 1a is a front view of an example of an invention device.

FIG. 1b is a magnified view of the indicated portion of FIG. 1 a.

FIG. 1c is a magnified view of the indicated portion of FIG. 1 a.

FIG. 2a is a front view of another example of an invention device.

FIG. 2b is a magnified view of the indicated portion of FIG. 2 a.

FIG. 2c is a magnified view of the indicated portion of FIG. 2 a.

FIG. 3a is a front view of another example of an invention device.

FIG. 3b is a magnified view of the indicated portion of FIG. 3 a.

FIG. 3c is a magnified view of the indicated portion of FIG. 3 a.

FIG. 4a is a front view of another example of an invention device.

FIG. 4b is a magnified view of the indicated portion of FIG. 4 a.

FIG. 4c is a magnified view of the indicated portion of FIG. 4 a.

FIG. 5a is a front view of another example of an invention device.

FIG. 5b is a magnified view of the indicated portion of FIG. 5 a.

FIG. 5c is a magnified view of the indicated portion of FIG. 5 a.

FIG. 6 is a front view of another embodiment of an invention device.

FIG. 7a is an end view showing the embodiment of FIG. 1 at section planeAA.

FIG. 7b is similar to FIG. 7a viewing section plane AA on a differentinvention embodiment.

FIG. 8a is an end view showing an embodiment of the device taken along asection plane similar to section plane BB.

FIG. 8b is similar to FIG. 8a viewing section plane AA on a differentinvention embodiment.

FIG. 9 is an end view of the device of FIG. 6.

The drawings are not necessarily drawn proportionally or to scale. Forexample, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity or several physical componentsmay be included in one functional block or element. Further, sometimesreference numerals may be repeated among the drawings to indicatecorresponding or analogous elements. Moreover, some of the blocksdepicted in the drawings may be combined into a single function.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a thorough understanding of the present invention.Those of ordinary skill in the art will know that the present inventionmay be practiced without these specific details. In other instances,well-known methods, procedures, components, or structures may not havebeen described in detail so as not to obscure the present invention.

The present invention is directed to systems and methods for treatmentof a vessel. The principles and operation of systems and methods of thepresent invention may be better understood with reference to thedrawings and accompanying descriptions.

The invention is not limited in its application to the details ofconstruction and the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments or of being practiced or carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein are for the purpose of description andshould not be regarded as limiting.

Certain features of the invention that are, for clarity, described inthe context of separate embodiments, may also be provided in combinationin a single embodiment. Conversely, various features of the inventionthat are, for brevity, described in the context of a single embodiment,may also be provided separately or in any suitable sub-combination.

Table of components. 100 scoring balloon (SCB) catheter 105 shaft 106shaft proximal section 107 shaft middle section 108 shaft distal section109 shaft wall 110 shaft distal end 111 shaft tapered section 112 shaftproximal end 113 shaft lumen 115 inflatable balloon (IB) 119 guidewirelumen (GWL) 120 GWL distal end 121 GWL outer surface 130 IB proximal end131 IB distal end 132 IB outer surface 133 IB lumen 135 scoring wire(SCW) 1351 SCW distal section 1352 SCW proximal section 136 fixed SCWend 1361 SCW lumen section 1362 weld joint 137 SCW IB section 138moveable SCW end 1139 SCW lumen 140 Hub 141 GWL passage 145 Hub lumen150 handle assembly (HA) 153 HA IB lumen port 154 HA GW port 155 HAdistal end point 156 HA stepped-down portion 200 spring 201 spring wire241 Hub distal section 242 hub proximal section 340 narrowed region 400fingergrip 451 extension 505 SCW cross-section 610 see IBL 700 Hub cover

DEFINITIONS

“fixed”—inseparable within the operational environment of the device.

“operational environment”—any environment in which the device wouldconceivably operate as an intravascular balloon catheter.

“longitudinally resilient”—the ability to repeatedly movelongitudinally.

“definition of mechanically communicating”—describes the ability of oneobject to connect sufficiently such that its movement causes anotherobject to move and vice versa.

“rail”—A substantially longitudinal object that supports and guides themovement of another object.

A “slidably engaged” component is a component that fits into apassageway or around a rail such that the component is largely orsubstantially constrained in two dimensions. Instead of the thirddimension constraining the component, the component is unconstrained tosome degree allowing the component to move longitudinally a substantialdistance within the passageway or along the rail. If the system hasstops or other components that curtail longitudinal movement, but stillpermit substantial longitudinal motion, the component is consideredslidably engaged.

“effectively engaged”—a scoring wire is effectively engaged when itengages the lesion well enough for the treatment to substantially affectthe lesion.

Invention catheters can be over-the-wire, short rapid exchange, or rapidexchange platform. If the catheter is a short rapid exchange platform,an inner member may traverse the entire length of the catheter.

Turning to the invention embodiments, FIG. 1a depicts an embodiment ofthe invention device. In this invention embodiment, a scoring balloon(SCB) catheter 100 is shown in a front view with selected sections shownin a magnified view. SCB catheter 100 comprises components as discussedbelow. For instance, catheter 100 comprises shaft 105. Shaft 105 hasshaft proximal section 106 connected to shaft middle section 107 andshaft middle section 107 connected to shaft distal section 108. Shafttapered section 111 joins shaft proximal section 106 to shaft middlesection 107. Shaft 105 also comprises shaft wall 109, which provides adegree of rigidity to shaft 105 such that shaft 105 is suitable (asjudged by those of ordinary skill in the art) for tracking intovasculature or tortuous vasculature being neither too rigid or tooflexible. In some embodiments, the rigidity or flexibility is modifiedby adding a longitudinal member (not shown) to SCB catheter 100. Shaft105 comprises Pebax, in some embodiments.

In some embodiments, shaft tapered section 111 is fixed to shaft middlesection 107. In some embodiments, shaft wall 109 ends before shaftdistal end 110 ends.

For purposes of this document, shaft distal end 110 is the end of shaft105 that enters the patient first. Similarly, any other“distal”-characterized component means the component portion closer toshaft distal end 110 then is any other component portion. Likewise, any“proximal”-characterized component means the component portion furtherfrom shaft distal end 110 then is any other component portion.

SCB catheter 100 further comprises inflatable balloon (IB) 115.Inflatable balloon 115 mounts to shaft 105 within shaft distal section108. In some embodiments, inflatable balloon 115 ends at shaft distalend 110. In these or other embodiments, inflatable balloon 115 is fixedto shaft 105.

Inflatable balloon 115 comprises IB proximal end 130 and IB distal end131. A typical embodiment has a flexible, polymeric film serving asinflatable balloon 115. IB outer surface 132 ends up facing abluminallyafter inflatable balloon 115 mounts to shaft 105. For this disclosure,IB proximal end 130 is the portion of inflatable balloon 115 thatattaches or fixes the proximal end of inflatable balloon 115 to shaft105. IB proximal end 130 is defined as the proximal portion ofinflatable balloon 115 that remains contacting shaft 105 afterinflatable balloon 115 is inflated.

For this disclosure, IB distal end 131 is the portion of inflatableballoon 115 that distally attaches or fixes inflatable balloon 115 toshaft 105. IB distal end 131 is defined as the distal portion ofinflatable balloon 115 that remains contacting shaft 105 afterinflatable balloon 115 in inflated.

IB lumen 133 fluidly communicates with inflatable balloon 115, whichallows inflatable balloon 115 to be inflated by fluid passing through IBlumen 133.

SCB catheter 100 further comprises guidewire lumen (GWL) 119, whichlongitudinally extends at least from shaft proximal end 112 to beyondshaft distal end 110. GW lumen 119 ends at GWL distal end 120.

In some embodiments, IB proximal end 130 and IB distal end 131 connectto GWL outer surface 121 or shaft 105 using any method known to those ofordinary skill in the art.

SCB catheter 100 further comprises scoring wire (SCW) 135. Scoring wire135 comprises fixed SCW end 136, SCW IB section 137, and movable SCW end138. Fixed SCW end 136 connects within shaft distal section 108 distalof IB distal end 131. In some embodiments, fixed SCW end 136 attaches toGWL outer surface 121. In other embodiments, fixed SCW end 136 attachesto the outer side of shaft wall 109. Fixed SCW end 136 attaches usingany method known to those of ordinary skill in the art.

This configuration provides for a focused force element (scoring wire135) alongside inflatable balloon 115.

The distance between scoring wire 135 and IB outer surface 132 can beany value recognized as useful by those of ordinary skill in the art.Once past inflatable balloon 115, scoring wire 135 dives below shaftwall 109, extending proximally inside of shaft 105. Movable SCW end 138sits inside of shaft 105 within shaft proximal section 106. In someembodiments, scoring wire 135 occupies at least part of SCW lumen 1139(shown in FIGS. 8a and 8b ).

FIG. 1a -FIG. 5b depicts SCB catheter 100 as having two scoring wires.In some embodiments, SCB catheter 100 has 1-15, 3-10, or 2-5 scoringwires. In some embodiments the diameter of SCW 135 is between 0.003inches and 0.040 inches, or 0.005 inches and 0.015 inches, 0.008 inchesand 0.012 inches. In some embodiments, SCW 135 is 0.10 inches. SCW 135need not have a uniform diameter. In some embodiments SCW distal section1351 has a diameter larger than SCW proximal section 1352. In someembodiments SCW distal section 1351 has a diameter smaller than SCWproximal section 1352. In some embodiments, SCW 135 comprises metals,metal alloys, polymers, and shape memory materials that are metal- orpolymer-based.

SCB catheter 100 further comprises hub 140. Hub 140 resides inside ofshaft 105 within shaft proximal section 106. Hub 140 comprises a GWLpassage 141 for guidewire lumen 119 to pass through. Hub 140 furthercomprises one or more hub lumens 145 that interact with movable SCW end138.

In some embodiments, the interaction encompasses movable SCW end 138connected in or to hub lumen 145. In some embodiments, movable SCW end138 is fixed to hub lumen 145. In other embodiments, the interactionencompasses movable SCW end 138 being slidably engaged inside of hublumen 145. In some embodiments hub 140 comprises any biocompatiblematerial such as metals, metal alloys, and polymers. In some embodimentshub 140 comprises nylon, Pebax, or any other suitable material known tothose of ordinary skill in the art.

In some embodiments hub 140 is substantially fixed inside shaft proximalsection 106 with movable SCW end 138 slidably engaged or disposed withinhub lumen 145. In some embodiments, hub 140 is longitudinally movable orelastic, allowing movable SCW end 138 to move longitudinally by pullinghub 140 distally, by moving hub 140 or by stretching material of hub140. For instance, in some embodiments, hub 140 is elastic. When movableSCW end 138 is subjected to a distally directed force that causes it tomove distally and when movable SCW end 138 is fixed to or within hublumen 145, the movement stretches hub 140. The restoring force or forcecounter to that distal stretching (counterforce) tends to move movableSCW end 138 substantially back into place when the distally directedforce is removed.

In some embodiments, hub 140 is biased by a spring 200. In someembodiments, spring 200 mounts distal to hub 140 and in someembodiments, spring 200 mounts proximal to hub 140.

SCW catheter 100 further comprises handle assembly 150. Handle assembly150 associates with shaft proximal end 109. Handle assembly 150comprises HA port sub-assembly and HA transition sub-assembly. HA portsub-assembly occupies at least part of the proximal end of handleassembly 150. And HA transition sub-assembly occupies at least part ofthe distal end of handle assembly 150. HA port sub-assembly relates toHA transition sub-assembly. In some embodiments, HA port sub-assemblyconnects to or is fixed to HA transition sub-assembly. In someembodiments, HA port sub-assembly and HA transition sub-assemblytogether form a monolithic object or a number of objects or monolithicobjects split by a plane containing SCW catheter 100's longitudinalaxis.

HA transition sub-assembly comprises HA stepped-down portion 156 locatedat the distal end of HA transition sub-assembly. In some embodiments thedistal end of HA transition sub-assembly and the distal end of handleassembly 150 are the same object.

HA stepped-down portion 156 is a portion of HA transition sub-assemblyin which the overall outside dimension has a step transition decreasingto a smaller diameter, sized to engage shaft proximal end 112.

In some embodiments, transition subassembly 152 does not have HAstepped-down portion 156.

Shaft 105 relates to handle assembly 150 through shaft proximal end 112and HA stepped-down portion 156. In some embodiments, shaft 105 connectsto handle assembly 150. For example, shaft proximal end 112 can slideover HA stepped-down portion 156 and the components can be fixed such asby welding, fusing, gluing, etc. Or the friction fit between shaftproximal end 112 and HA transition sub-assembly can be strong enough tofix the components together. In some embodiments lacking HA stepped-downportion 156, shaft proximal end 112 can connect to handle assembly 150through a butt joint between shaft proximal end 112 and HA transitionsubassembly 152.

HA port sub-assembly comprises HA GW port 154, which occupies theproximal end of HA port sub-assembly. In some versions of handleassembly 150, HA GW port 154 points away or directly away from shaftdistal end 110. HA GW port 154 allows access from outside of SCBcatheter 100 into guidewire lumen 119. In some versions of handleassembly 150, HA port subassembly also comprises HA IB lumen port 153,which angles out from the longitudinal axis of SCB catheter 100 at anyof a variety of angles recognized as useful to those of ordinary skillin the art. In some versions, HA IB lumen port 153 flows into theguidewire-port-guidewire-lumen region and in other embodiments flows toa separate lumen inside or outside (not shown) of guidewire lumen 119.HA IB lumen port 153 also allows access from outside of SCB catheter 100into a passageway (guidewire lumen 119 or IB lumen 133 (IBL)) thatcarries gas or inflation fluid into inflatable balloon 115 to inflate itor carries gas or inflation fluid out of inflatable balloon 115 todeflate it.

Operationally, in the devices taught by the FIG. 1a embodiment, fortreatment of calcified lesions, for example, a physician cuts throughthe patient's tissue until an appropriately sized vessel is revealed.The vessel must lead to the lesion site following a path that SCBcatheter 100 can follow. In some embodiments, the location of the lesionsite causes those of ordinary skill in the art to select a more or lessflexible shaft 105 or SCB catheter 100.

The physician opens the vessel, inserts a guidewire into the vessel, andadvances the guidewire through the patient's vasculature underultrasound, magnetic resonance, fluoroscopic, or some other type ofguidance. Once the physician places the guidewire at a satisfactorysite, the physician threads the proximal end of the guidewire into GWLdistal end 120, through guidewire lumen 119, and ultimately out of SCBcatheter 100 through HA GW port 154. With the guidewire in place andinstalled in SCB catheter 100, the physician maneuvers SCB catheter 100along the guidewire until inflatable balloon 115 reaches the desiredposition near the lesion site. Typically, this position will allow atleast one scoring wire 135 to effectively engage the lesion. After that,the physician inflates inflatable balloon 115 until scoring wire 135firmly presses into or cracks the lesion. Once lesion treatment with SCBcatheter 100 is complete, the physician deflates inflatable balloon 115,which allows scoring wire 135 to relax away from the lesion and from thevessel wall.

Scoring wire 135 contacts the lesion as long as inflatable balloon 115remains inflated. The inflation time corresponds to the time thephysician chooses for scoring wire 135 to contact the lesion. Those ofordinary skill in the art use inflation times of 5 seconds to 5 minutes.Those of ordinary skill in the art look to the nature of the lesion indetermining the appropriate inflation time and inflation speed.

An aspect of this invention includes the behavior of scoring wire 135during balloon inflation and specifically includes the behavior ofmovable SCW end 138.

As inflatable balloon 115 inflates, scoring wire (or wires) 135 expandsoutwardly, placing scoring wire 135 under longitudinal tension. Acomponent of the force vector caused by that longitudinal tension pointsproximally from fixed SCW end 136 and distally from movable SCW end 138.But fixed SCW end 136 is fixed to shaft 105 or GWL outer surface 121.Therefore, any movement of scoring wire 135 occurs at movable SCW end138. Hub 140 constrains the movement of movable SCW end 138 allowing itto move longitudinally. This movement decreases the strain on inflatableballoon 115 helping to maintain its engineered shape and helping toavoid any kinking in the balloon's net, which was sometimes seen inprior art devices having scoring wires substantially fixed at both ends.

When the physician deflates the balloon, the forces previously causingscoring wire 135 to expand disappear, allowing scoring wire 135 (andmovable SCW end 138) to relax. Hub 140 constrains the relaxation ofmovable SCW end 138. Specifically, hub 140 guides movable SCW end 138into an arrangement similar to the initial arrangement of movable SCWend 138 before balloon inflation. Hub 140's action helps regularize theinflation and deflation steps increasing their predictability.

Returning to FIG. 1a , FIG. 1a depicts the catheter as described above.The specific shaft 105 can be made by a variety of methods as known tothose of ordinary skill in the art. The embodiment shown in FIG. 1acomprises shaft 105 coupled (attached, connected, joined) to handleassembly 150 through HA distal end portion 155 and HA stepped-downportion 156. HA stepped-down portion 156 occupies shaft lumen 113 andsubstantially seals shaft proximal end 112 from the atmosphere. In someembodiments, shaft proximal end 112 and HA distal end portion 155 areglued together with an adhesive. In other embodiments, an adhesive isnot used. Those of ordinary skill in the art know of other joiningmethods. These are considered to be within the scope of the currentinvention.

In FIG. 1a , HA stepped-down portion 156 sits midway along HA distal endportion 155's length. Moreover, in this embodiment HA distal end portion155 also serves as hub 140. The reference numbers refer to the samecomponent because the component serves both as HA distal end 155 and ashub 140.

FIG. 1b is magnified view of shaft proximal section 106. Shaft 105 endsat shaft proximal end 112 and receives hub 140, which is either part ofHA distal end 155 or not. Hub 140 can have one or more hub lumens145—FIG. 1b shows two hub lumens 145. These hub lumens 145 extend intohub 140 longitudinally in this embodiment. But SCB catheter 100 does notneed lengthwise hub lumens 145 to function correctly. Hub lumens 145need only function to slidably and reversibly receive movable SCW end138. FIG. 1b shows hub lumens 145 extending into hub 140 approximatelythree quarters of hub 140's length, but this is not critical. In someembodiments, hub lumens 145 extend completely through hub 140. Hublumens 145 extend into hub 140 as far as or further than movable SCW end138 extends into hub lumen 145. FIG. 1b also shows scoring wire 135 andmovable SCW end 138. In this embodiment, scoring wire 135 tapers orflares outwardly after proximally exiting SCW lumen 1139. Movable SCWend 138 occupies a portion of hub lumen 145. In this embodiment, SCBcatheter 100 comprises one hub lumen 145 per movable SCW end 138. Butother embodiments exist in which a hub lumen can interact with more thanone movable SCW end 138.

Finally, FIG. 1b shows guidewire lumen 119 passing through hub 140 andcontinuing into shaft 105. FIG. 1c depicts a magnified view of theregion where scoring wire 135 distally exits SCW lumen 1139.

Scoring wire 135 has a path through part of SCB catheter 100. SCW lumen1139 is a lumen that receives scoring wire 135 along some or all ofshaft middle section 107. We refer to the portion of scoring wire 135within SCW lumen 1139 as SCW lumen section 1361. And we refer to thesection of scoring wire 135 near inflatable balloon 115 as SCW IBsection 137.

For discussion purposes, we begin the path at movable SCW end 138.Movable SCW end 138 resides within hub lumen 145. As we move distallyalong scoring wire 135, we come to the proximal end of SCW lumen 1139,which scoring wire 135 occupies. In some embodiments, scoring wire 135tapers inwardly proximally of SCW lumen 1139. Scoring wire 135 distallyexits SCW lumen 1139 at the lumen's distal end. We refer to the sectionof scoring wire 135 that begins at this exit as SCW IB section 137.After exiting, scoring wire 135 flares outward as it progressesdistally, extending in a substantially longitudinal direction until thewire is past IB distal end 131. At that point scoring wire 135 turnsinwardly until it reaches shaft distal section 108 or GWL outer surface121. Fixed SCW end 136 attaches to SCB catheter 100 distally ofinflatable balloon 115 or at or near the point where IB distal end 131attaches to SCB catheter 100. The portion of scoring wire 135 within SCWIB section 137 has a longitudinal region along inflatable balloon 115.The distance this longitudinal section extends from SCB catheter 100'scentral axis (wire distance) can have a variety of values. The distancethat IB outer surface 132 extends from the central axis when inflatableballoon 115 inflates is the balloon inflation distance. Typically,(wired distance)/(balloon inflation distance) is within the followingranges 0.99-1.01; 0.90-1.1; 0.8-1.2; and 0.5-1.5.

In the operation of the group of embodiments represented by the devicein FIG. 1a , a physician places inflatable balloon 115 as describedabove. The physician inflates inflatable balloon 115 through HA IB lumenport 153. Balloon inflation first applies outward pressure on scoringwires 135 and then onto the lesion. Without wishing to be bound by anyparticular theory of operation, we believe that because movable SCW end138 is moveably connected, scoring wire 135 does not contribute toballoon or balloon deformation caused by inflation or overinflation.Since the wire can move outwardly, it does not significantly cage theballoon. The caging effect will prevent the balloon from expanding pastthe wires. But if inflation continues, some other portion of the balloonwill deform from the pressure exerted by the inflation fluid. In somecases balloon deformation leads to problems with later deflating theballoon. Instead, the outwardly directed inflation pressure on scoringwire 135 causes movable SCW end 138 to move distally, which lowers thecounterforce that scoring wire 135 exerts against inflatable balloon115. As movable SCW end 138 moves distally, it recedes from hub lumen145. In some embodiments, inflation pressure causes movable SCW end 138to pull out of hub lumen 145. In other embodiments, movable SCW end 138remains inside of hub lumen 145.

The physician maintains pressure in inflatable balloon 115 long enoughfor scoring wire 135 to have the effect the physician desires.Afterward, the physician releases pressure, inflatable balloon 115deflates, and movable SCW end 138 re-extends into hub lumen 145.

FIGS. 2a through 2c depict different embodiments of SCB catheter 100.These embodiments are similar to those shown in FIGS. 1a through 1c .The main difference between the sets of embodiments lies in the hub andthe proximal scoring wire geometry.

FIG. 2b depicts a hub 140 that has hub distal section 241 and hubproximal section 242. Hub proximal section 242 through HA stepped-downportion 156 serves to connect shaft 105 with handle assembly 150.Additionally, hub proximal section 242 serves as a stop for spring 200.Spring 200 comprises spring wire 201—the figure depicts spring wire 201in cross-section. Spring 200 adds resilience to the mechanism of scoringwire 135.

Hub distal section 241 lies next to the distal end of spring 200. Hubdistal section 241 connects (attaches) to movable SCW end 138. In someembodiments, hub distal section 241 is fixed to movable SCW end 138. Inother embodiments, hub distal section 241 comprises hub lumens 145,which in some cases are fixed to movable SCW end 138. Movable SCW end138 flares outwardly as it reaches hub distal section 241. In thisembodiment, on the other hand, the embodiment shown in FIG. 3a through3c comprise movable SCW ends 138 that do not flare as it reaches hubdistal section 241.

In the operation of the group of embodiments represented by the devicesdisclosed in FIGS. 1a -6, a physician places inflatable balloon 115 asdescribed above. The physician inflates inflatable balloon 115 throughHA IB lumen port 153, which first applies outer pressure on scoringwires 135 and then on the lesion. The difference in operation betweenthe above embodiments and the group of embodiments represented by FIGS.1a3c is in the mechanism that that allows movement by movable SCW end138. As in the above embodiments, in these embodiments, as inflatableballoon 115 inflates, the counterforce that scoring wire 135 wouldotherwise apply, is moderated by movable SCW end 138. In this group,movable SCW end 138 recedes distally as before, but hub distal section241 also moves distally. The arrangement of hub distal section 241,spring 200, and hub proximal section 242 imparts force, through hubdistal section 241, to movable SCW end 138. This force tends toproximally bias movable SCW end 138. And when the physician deflates theballoon as before, movable SCW end 138 moves proximally, substantiallyback to its initial position, aided by the force of spring 200.

FIGS. 4a-4b depict another embodiment of SCB catheter 100. The device ofthis embodiment is substantially similar to the embodiments describedabove. The main difference is that this version of hub distal section241, although similar to hub distal sections described above, hasnarrowed region 340 that extends proximally from hub distal section 241.Narrowed region 340 sits inside of spring 200.

Similarly, FIG. 5a has narrowed region 340 and additionally hasextension 451 sitting between hub distal section 241 and narrowed region340. Finger grip 400 sits on extension 451, extending through the sideof shaft proximal section 106. Finger grip 400 provides the physiciansome control of distal hub 450, which enables more direct control ofmovable SCW end 138 in these types of embodiments.

FIG. 6 discloses an embodiment of the proximal section of the device. Inthis embodiment a spring 200 sits within the distal end of HA 150 andextends distally from HA 150. Hub 140 connects to HA 150 and forms amonolithic structure with HA 150. Spring 200 receives shaft proximalsection 106. Movable SCW end 138 exits scoring wire lumen 1139 near thedistal end of shaft proximal section 106. Movable SCW end 138 connectsdirectly to spring 200 through any suitable method, such as soldering,welding, overmolding, gluing, or press fitting using plastic tubing. Insome embodiments, movable SCW end 138 connects directly to spring 200through a weld joint 1362. In this or other embodiments, hub cover 700sits over hub 140 and shaft 105. In some cases, hub cover 700 providesstrain relieve for the connection between HA 150 and shaft 105.

The spring 200 provides longitudinal movement and a biasing force tomovable SCW end 138. When movable SCW end 138 experiences a distallydirected force that moves it distally, the movement holds that away fromHA 150. The restoring force or force counter to that distal stretching(counterforce) tends to move movable SCW end 138 substantially back intoplace once the distally directed force disappears.

FIG. 7a depicts section AA of FIG. 1a . It shows two scoring wires 135,inflatable balloon 115, IB lumen 133, and guidewire lumen 119. As can beseen, section plane AA cuts through SCB catheter 100 at shaft distalsection 108. The plane also cuts inflatable balloon 115; cuts scoringwire 135 at SCW IB section 137 showing SCW cross-section 505; and cutsguidewire lumen 119. FIG. 7b depicts a similar embodiment, but withthree scoring wires 135.

FIG. 8a depicts section BB of FIG. 1a . It shows two SCW lumens 1139sitting side-by-side. It also shows IB lumen 133 and GW lumen 119. SCWlumen 1139 need not adopt a side-by-side configuration, as shown in thisfigure, but can adopt a configuration distributed around the perimeterof shaft 105.

FIG. 8b shows a different embodiment similar to FIG. 1a incross-section. Shaft proximal section 106 is cut proximally of shafttapered section 111. Shaft tapered section 111 tapers from shaftproximal section 106 to shaft middle section 107. Shaft 105 has shaftwall 109. For example, FIG. 8b depicts two SCW lumens 1139 distributedacross from each other in shaft 105. This distribution need not besymmetric. Also in this figure, guidewire lumen 119 lies within shaft105, and it shows SCW lumen 1139 extending longitudinally inside ofshaft 105. In some embodiments, SCW lumens sit outside of the guidewirelumen.

FIG. 9 shows the embodiment of FIG. 6 in cross-section. In this figure,guidewire lumen 119 lies within shaft 105. In some embodiments, shaft105 is an extrusion providing guidewire lumen 119, two SCW lumen 1139,and one lumen 133.

In any of the embodiments set out above, inflatable balloon 115 can haveany of a variety of diameters ranging from 1.25-40 mm or 2.0-8.0 mm. Inany of the embodiments set out above, inflatable balloon 115 can haveany of a variety of lengths such as 10-300 mm or 20-300 mm. Longballoons may be particularly useful for treating peripheral lesions,which often have long diseased portions.

In all of the systems described above, a coating such as a hydrophobicor hydrophilic coating may be added externally to provide ease ofinsertion.

Suitable drugs or therapeutic agents include the following substances.

Antimicrobial agents may be selected, for example, from triclosan fromtriclosan, chlorhexidine, nitrofurazone, benzalkonium chlorides, silversalts and antibiotics such as rifampin, gentamycin and minocyclin andcombinations thereof, among others.

In certain embodiments, antimicrobial agents may include triclosan,chlorhexidine and salts or combinations thereof. Anti-inflammatoryagents include steroidal and non-steroidal anti-inflammatory agents.Examples of nonsteroidal anti-inflammatory drugs includeaminoarylcarboxylic acid derivatives such as enfenamic acid,etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamicacid, niflumic acid, talniflumate, terofenamate and tolfenamic acid;arylacetic acid derivatives such as acemetacin, alclofenac, amfenac,bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac,fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin,ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinicacid, oxametacine, proglumetacin, sulindac, tiaramide, tolmetin andzomepirac; arylbutyric acid derivatives such as bumadizon, butibufen,fenbufen and xenbucin; arylcarboxylic acids such as clidanac, ketorolacand tinoridine; arylpropionic acid derivatives such as alminoprofen,benoxaprofen, bucloxic acid, carprofen, fenoprofen, flunoxaprofen,flurbiprofen, ibuprofen, ibuproxam, indoprofen, ketoprofen, loxoprofen,miroprofen, naproxen, oxaprozin, piketoprofen, pirprofen, pranoprofen,protizinic acid, suprofen and tiaprofenic acid; pyrazoles such asdifenamizole and epirizole; pyrazolones such as apazone, benzpiperylon,feprazone, mofebutazone, morazone, oxyphenbutazone, phenybutazone,pipebuzone, propyphenazone, ramifenazone, suxibuzone andthiazolinobutazone; salicylic acid and its derivatives such asacetaminosalol, aspirin, benorylate, bromosaligenin, calciumacetylsalicylate, diflunisal, etersalate, fendosal, gentisic acid,glycol salicylate, imidazole salicylate, lysine acetylsalicylate,mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine,parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide,salicylamine a-acetic acid, salicylsulfuric acid, salsalate andsulfasalazine; thiazinecarboxamides such as droxicam, isoxicam,piroxicam and tenoxicam; others such as Eacetamidocaproic acid,s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine,bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone,guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline,perisoxal, pifoxime, proquazone, proxazole and tenidap; andpharmaceutically acceptable salts thereof.

Examples of steroidal anti-inflammatory agents (glucocorticoids) include21-acetoxyprefnenolone, alclometasone, algestone, amicinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumehtasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol priopionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methyolprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylaminoacetate, prednisone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortal, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, and pharmaceutically acceptable salts thereof.

Analgesic agents include narcotic and non-narcotic analgesics. Narcoticanalgesic agents include alfentanil, allylprodine, alphaprodine,anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol,clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeinesulfate, desomorphine, dextromoramide, dezocine, diampromide,dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine,dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate,dipipanone, eptazocine, ethoheptazine, ethylmethlythiambutene,ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone,hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil,meperidine, meptazinol, metazocine, methadone hydrochloride, metopon,morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol,normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone,papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine,piminodine, piritramide, proheptazine, promedol, properidine, propiram,propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceuticallyacceptable salts thereof. Non-narcotic analgesics include aceclofenac,acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid,alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate),aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine,ammonium salicylate, amtolmetin guacil, antipyrine, antipyrinesalicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen,benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide,5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin,calcium acetylsalicylate, carbamazepine, carbiphene, carsalam,chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen,ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol,difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate,dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole,etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone,flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazolesalicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin,ketoprofen, ketorolac, plactophenetide, lefetamine, loxoprofen, lysineacetylsalicylate, magnesium acetylsalicylate, methotrimeprazine,metofoline, miroprofen, morazone, morpholine salicylate, naproxen,nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide,perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll,phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol,pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone,proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate,salacetamide, salicin, salicylamide, salicylamide a-acetic acid,salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate,sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate,tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol,xenbucin, zomepirac, and pharmaceutically acceptable salts thereof.

Local anesthetic agents include amucaine, amolanone, amylocainehydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine,bupivacaine, butacaine, butaben, butanilicaine, butethamine,butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene,cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin,dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine,ethyl chloride, betaeucaine, euprocin, fenalcomine, fomocaine,hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate,leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine,metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine,orthocaine, oxethazaine, parethoxycaine, phenacaine hydrochloride,phenol, piperocaine, piridocaine, polidocanol, pramoxine, prilocaine,procaine, propanocaine, proparacaine, propipocaine, propoxycainehydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl alcohol,tetracaine hydrochloride, tolycaine, trimecaine, zolamine, andpharmaceutically acceptable salts thereof.

Antispasmodic agents include alibendol, ambucetamide, aminopromazine,apoatropine, bevonium methyl sulfate, bietamiverine, butaverine,butropium bromide, n-butylscopolammonium bromide, caroverine,cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide,coniine hydrochloride, cyclonium iodide, difemerine, diisopromine,dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide,ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiveriniumbromide, fentonium bromide, flavoxate, flopropione, gluconic acid,guaiactamine, hydramitrazine, hymecromone, leiopyrrole, mebeverine,moxaverine, nafiverine, octamylamine, octaverine, oxybutynin chloride,pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaveriumbromide, piperilate, pipoxolan hydrochloride, pramiverin, prifiniumbromide, properidine, propivane, propyromazine, prozapine, racefemine,rociverine, spasmolytol, stilonium iodide, sultroponium, tiemoniumiodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,trifolium, trimebutine, n,n-1 trimethyl-3,3-diphenyl-propylamine,tropenzile, trospium chloride, xenytropium bromide, and pharmaceuticallyacceptable salts thereof.

In certain embodiments, therapeutic agents for reducing pain ordiscomfort may be selected from ketorolac and pharmaceuticallyacceptable salts thereof (e.g., the tromethamine salt thereof, soldunder the commercial name Torado®),4-diethylamino-2-butynylphenylcyclohexylglycolate and pharmaceuticallyacceptable salts thereof (e.g.,4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride, alsoknown as oxybutynin chloride, sold under the commercial nameDitropang®), and combinations thereof. The amount of therapeutic agentpresent, will depend, for example, upon the efficacy of the therapeuticagent employed, the release rate, and so forth. One skilled in the artcan readily determine an appropriate therapeutic agent loading toachieve the desired outcome.

In some embodiments, the surface of IB 115 is embossed with any of avariety of patterns. For example, in some embodiments the surface of IB115 is embossed with a checkered pattern. Additionally, in someembodiments, inflatable balloon 115 tapers along its longitudinaldirection.

In some embodiments, scoring wire 135 sits within SCW lumen 1139. And insome embodiments, SCW lumen 1139 sits outside of shaft 105.

Although the invention has been described in conjunction with specificembodiments, many alternatives, modifications, and variations will beapparent to those skilled in the art. Accordingly, it embraces all suchalternatives, modifications, and variations that fall within theappended claims' spirit and scope. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

The invention claimed is:
 1. A scoring balloon catheter that comprises:a shaft; an inflatable balloon mounted on the shaft's distal section; ahub contacting a spring, said hub associated with the shaft, proximal tothe balloon, said hub including a hub distal section distal to thespring and a hub proximal portion proximal to the spring; and at leastone scoring wire having: a fixed end mounted on the shaft between ashaft distal end and the balloon; a longitudinally movable end attachedto the hub distal section; and an intermediate portion running alongsideof the balloon; wherein the hub proximal portion is fixed with respectto the shaft and the hub distal portion is located within the shaft andis moveable relative to the shaft.
 2. The catheter of claim 1 whereinthe spring supplies a longitudinal resilience to the scoring wire. 3.The catheter of claim 2 wherein the hub is mounted at least partiallyinside of the proximal half of the shaft.
 4. The catheter of claim 3further comprising at least two lumens and wherein the at least onescoring wire comprises two to eight scoring wires, and wherein each ofthe lumens is associated with one or more of the two to eight scoringwires.
 5. The catheter of claim 4 wherein the at least one scoring wirecomprises three scoring wires.
 6. The catheter of claim 4 wherein the atleast one scoring wire comprises two scoring wires.
 7. The catheter ofclaim 6 comprising a lumen for each scoring wire.
 8. The catheter ofclaim 7 wherein the movable ends of the scoring wires taper outwardly.9. The catheter of claim 8 further comprises a fingergrip at leastpartially outside of the shaft and mechanically communicating with thehub.
 10. The catheter of claim 1, wherein the spring is biased againstthe hub.
 11. A scoring balloon catheter comprising: a shaft; a guidewirelumen; an inflatable balloon mounted on a shaft distal end; a handleassembly located at a shaft proximal end comprising: a port sub-assemblycomprising: a guidewire port substantially in line with the shaft; and aballoon port at an angle to the shaft; and a transition sub-assemblyextending distally from the port sub-assembly comprising a stepped-downportion that is positioned within at least a portion of the shaftproximal end, a hub associated with the shaft, said hub including a hubproximal section, a hub distal section, and a spring therebetween,wherein the hub proximal section is a part of the transitionsub-assembly; and two scoring wires having: fixed ends mounted on theshaft between the shaft distal end and the balloon; longitudinallymovable ends with an outward taper, entering the shaft near the shaft'sdistal end and extending proximally, wherein at least one movable end isattached to the hub distal section; and an intermediate portion disposedoutside of the balloon, wherein the hub distal section is longitudinallymoveable with respect to the shaft.
 12. A scoring balloon cathetercomprising: a polymeric shaft having a distal region, a distal end, anda proximal end; an inflatable balloon mounted at the distal region ofthe shaft; an inflation lumen with a distal end and a proximal endwherein the distal end ends inside of the balloon; a guidewire lumensitting inside of the shaft; a handle mounted at the proximal end of theshaft having: a guidewire port connecting to a proximal end of theguidewire lumen; and a balloon inflation port connected to a proximalend of the inflation lumen; a hub including a spring, said hub mountedat the distal end of the handle with said spring coaxial with the shaft;two scoring wire lumens inside of the shaft on one side of the shaft,next to the guidewire lumen, having distal ends that begin proximally ofthe balloon and having proximal ends that end distally of the spring;two scoring wires, one in each scoring wire lumen, having: ends mountedon the shaft between the shaft's distal end and the balloon;intermediate portions longitudinally tracing the outside of the balloon;proximal portions located inside of the scoring wire lumens; andproximal ends welded to the spring; and a hub cover surrounding at leasta portion of the hub and the spring, said hub cover connected at adistal end to the shaft and at a proximal end to the handle.
 13. Thecatheter of claim 12 wherein the spring at least partially surrounds theshaft and sits at least partially within the hub.
 14. The catheter ofclaim 13 wherein the hub at least partially surrounds the shaft.
 15. Thecatheter of claim 13 wherein the longitudinally movable end is attachedto an outer surface of the spring.
 16. The catheter of claim 15 whereinthe longitudinally movable end is welded to the outer surface of thespring.
 17. The catheter of claim 15 comprising at least two lumens andtwo to eight scoring wires wherein each of the lumens is associated withone or more wires.
 18. The catheter of claim 17 comprising two scoringwires.
 19. The catheter of claim 18 comprising a lumen for each scoringwire.
 20. The catheter of claim 19 wherein the movable ends taperoutwardly.
 21. The catheter of claim 12, wherein the proximal ends ofthe two scoring wires are welded to a distal portion of the spring suchthat the spring exerts a proximal force on the two scoring wires.